Catalog Number UNK HIP FEMORAL HEAD METAL ASR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/17/2011 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Follow-up is being conducted to obtain lawyer contact information.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Pc was created to capture for the left hip patient alleges pain with elevated cobalt and chromium levels.Doi: (b)(6) 2009.Dor: (b)(6) 2011.Left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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